Kornimate/medical-research-clean huggingface dataset:
community pediatric acceptability study (cpas)

Conditions: Otitis

Summary: ear infections, or otitis media, are a leading cause of health expenditures and antimicrobial prescriptions in children. diagnosis of otitis media requires the ability to view the tympanic membrane. an instrument called an otoscope with a light source and a magnifying lens with a plastic tip that conforms to the ear canal is currently the standard of care for examining the tympanic membrane. interpretation of otoscopic examinations is operator-dependent and cannot be seen by anyone other than the person holding the otoscope. a pocket size attachment that uses the technology and light source of a smartphone to capture images of the ear canal and tympanic membrane facilitates image documentation of the otic examination. in previous studies with the device, the investigators have shown that image quality of photographs of the tympanic membrane taken with the smartphone otoscope are equivalent to those taken with a camera-fitted conventional otoscope. in this study, the community provider assessment study (cpas), the investigators will perform a cross-sectional study in which they will randomly assign 3-4 pediatricians to use a smartphone otoscope as the standard of care device for all ear examinations and 3-4 pediatricians to use a conventional otoscope for alternating 1 month periods for 6 months. the parents of children examined during the study period with both devices will be invited to participate in 3 telephone surveys assessing parental satisfaction with the device and antimicrobial use by their child for the otic complaint. the results of this study have the potential to improve diagnosis and management of otitis media, thus improving patient care, reducing costs, and decreasing the opportunity for the development of antimicrobial resistance.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of an otic complaint * willing to undergo otoscopy exclusion criteria: * unwilling or unable to to complete study telephone questionnaires * do not meet inclusion criteria
phase ii study to evaluate efficacy and safety of d-0120 in combination with allopurinol in subjects with gout

Conditions: Gout

Summary: d-0120 is being tested in combination with allopurinol in adult subjects with gout.


Eligibility criteria:
inclusion criteria: * gout subjects meeting 2015 acr/eular gout classification criteria with inadequate urate-lowering response * subject has had at least 2 gout flares in the previous 12 months. * body mass index (bmi) between 18.0 and 45.0 kg/m2 (inclusive). * male and female subjects must agree to abstain or use effective contraception methods from the time of signing icf and for the duration of study participation through 30 days after the last dose of study drug. * subjects must have adequate clinical laboratory and ecg results as assessed by the principal investigator exclusion criteria: * subjects with significant comorbidities, inadequate lab function, current (and within the past 5 years) diagnosis of cancer or any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study. * women who are pregnant or breastfeeding
the effect of labor dance on traumatic birth perception and comfort

Conditions: Labor Pain; Fear of Childbirth

Summary: ne of the non-pharmacological methods that provide opportunities such as massage and freedom of movement with the support of the spouse / partner is the birth dance. in order to reduce the pain perceived by the woman and provide emotional support, the birth dance is started in the active phase of the first phase of the labor and continues until the end of the first phase. the woman is given the opportunity to act rhythmically with a relaxing light music with someone she prefers (spouse / partner, mother, midwife, etc.). the hands of the pregnant woman dance in the form of swinging from left to right, on the shoulder of his wife, with music; the partner is massaged by the sacrum area. it is aimed to increase the effectiveness of the method applied by adding spouse / partner support, upright posture and massage in addition to the music and body movements that dance includes, and also to provide emotional support to the woman. in this study, it was aimed to evaluate the effect of birth dance on traumatic birth perception and comfort.

the study was planned as randomized controlled. pregnant women and their accompanying persons assigned to the study group will be informed about working in the tram room where the pregnant woman is before the active phase begins 'using the labor dance practice guide (annex 3) and cervical dilatation 4 cm. they will be asked to practice in accordance with this guide. details of the application (such as dance time, rest time) will be recorded in the 'labor dance control guide' (annex 4) by the researcher. pregnant women will be followed by the doctor and midwife responsible for the pregnancy during the tram, and the researcher will not be involved in tram follow-up of the pregnant woman (cervical dilation, pediatric heart sound, contraction follow-up, vital signs of the pregnant woman).

Eligibility criteria:
inclusion criteria: * those who were admitted to hospital for labor * those whose cervical dilatation between 4 and 8 cm. exclusion criteria: * when delivered by cesarean sectio, * labor was inducted * narcotic analgesics used
complex sleep apnea syndrome (compsas) resolution study

Conditions: Complex Sleep Apnea Syndrome

Summary: the purpose of this study is to determine whether adaptive servo-ventilation (asv) or continuous positive airway pressure (cpap) is better at treating complex sleep apnea over time.

between 3 and 19% of patients with clinical and polysomnographic features of obstructive sleep apnea syndrome (osa) develop a high-frequency of central apneas and/or disruptive cheyne-stokes respiratory syndrome after application of continuous positive airway pressure (cpap), a pattern called the complex sleep apnea syndrome (compsas). the trial seeks to determine the efficacy of the asv vs. cpap modes for the treatment of compsas over time. baseline clinical and laboratory data will be collected, patients will be randomized to one of the two treatments. overall study participation is approximately 3 months.

Eligibility criteria:
inclusion criteria: * diagnosis of complex sleep apnea syndrome (compsas) * naive to pap therapy * requires cpap ≤15 cm h2o exclusion criteria: * requires supplemental oxygen or with a baseline sao2 \<90% * requires cpap \> 15 cm h2o * primary diagnosis of moderate to severe chronic obstructive pulmonary disease, neuromuscular disease, chronic hyperventilation, stroke, cognitive impairment, such that could impair ability to answer subjective questions (study questionnaires) or unstable heart failure * any contraindication for nasal or oro-nasal positive airway pressure, such as claustrophobia, severe nasal obstruction, or impaired mental status
pilot study of diet and behavior in children with autism

Conditions: Autism

Summary: we hypothesize that in children with autism dietary antigens can change the intestine, making it "leaky" and then affecting the brain changing their behavior.

subjects in 2 different diets (gluten/dairy and placebo) will be monitored for changes in intestinal permeability (urine lactulose mannitol ratio) and behavior (psychometric testing).

Eligibility criteria:
inclusion criteria: * children between the ages of 3 and 12 years, * dsm-iv (apa, 2000) diagnosis of autistic disorder (dsm-iv 299.90), * willingness to follow and maintain a gluten-free-dairy-free-diet for 4 weeks. exclusion criteria: * food allergies, * celiac disease, * inflammatory bowel disease, * infectious gastrointestinal, * seizure disorder, * neurological problems with behavioral changes, * unwillingness to undertake the dietary challenge with milk and gluten or to maintain a gluten-free-dairy-free-diet during the study were excluded

Keywords: intestinal permeability diet gluten dairy
study of repetitive transcranial magnetic stimulation (rtms) as adjuvant treatment for depression

Conditions: Depression

Summary: the study will systematically investigate the use of repetitive transcranial magnetic stimulation (rtms) in non-remitters of a selective serotonin reuptake inhibitor (ssri) followed by a serotonin-norepinephrine reuptake inhibitor (snri) trial with the capacity to identify gene variants that predict rtms response.

this is the first study of its kind to systematically investigate the use of repetitive transcranial magnetic stimulation (rtms) in non-remitters of a selective serotonin-reuptake inhibitor (ssri) followed by an serotonin-norepinephrine reuptake inhibitor (snri) trial with the capacity to identify gene variants that predict rtms response. the study is similar in design to the star\*d study in that it will be the third treatment stage for a study of subjects with major depressive disorder (mdd). rtms is a novel intervention which was fda approved for treatment of mdd in october 2008 and was not clinically available at the time of the star\*d study. the primary aim of this pilot study is to provide 10 hertz (hz) repetitive transcranial magnetic stimulation (rtms) applied to the left dorsolateral prefrontal cortex (l-dlpfc) as adjuvant treatment for depression in individuals who have not had a remission of their depressive symptoms after an 8 week trial of an ssri (citalopram or escitalopram) followed by an 8 week trial of an snri, duloxetine and identify gene variants associated with improvement of their depressive symptoms.

Eligibility criteria:
inclusion criteria * subjects whose depressive symptoms have not remitted during their participation in the "pharmacokinetics and pharmacodynamics of citalopram and escitalopram" study or the "pharmacokinetics and pharmacodynamics of duloxetine" study * must be able to continue to take same dose of duloxetine through the course of the study exclusion criteria * a history of failure for respond to electroconvulsive therapy (ect) * any metal in the head (except in mouth) * implanted medication pump or cardiac pacemaker * have had prior brain surgery * have unprovoked seizure disorder or family history of treatment resistant epilepsy * pregnancy * psychiatric hospitalization within the past two weeks * suicide attempt with hospitalization within past three months

Keywords: depression rtms
prognostic value of new cardiac biomarkers in elderly patients undergoing cardiac surgery

Conditions: Cardiac Surgery

Summary: to evaluate the use of new cardiac biomarker for the prediction of in-hospital cardiovascular complications in elderly patients undergoing elective cardiac surgery.

plasma n-terminal pro-brain natriuretic peptide (nt-probnp, cardiac troponin t (ctnt), pregnancy-associated plasma protein a (papp-a), ischemia-modified albumin (ima), myeloperoxidase (mpo), metalloproteinase (mmp) soluble cd 40 ligand (scd40l), and inflammatory cytokine levels will be measured in 100 elderly patients undergoing elective cardiac surgery with cardiopulmonary bypass before induction of anesthesia and 12 h, 24 h, and 48 h after surgery. optimum discriminators for prediction of postoperative cardiovascular complications wil be determined by the use of receiver operating characteristics (roc) curves analyses.

Eligibility criteria:
inclusion criteria: * patients aged 75 years or older undergoing elective cardiac surgery with cpb exclusion criteria: * positive cardiac troponin t test within the week before surgery * patients undergoing emergent procedures * patients with preoperative mechanical cardiac support * patients undergoing hemodialysis

Keywords: cardiac biomarker cardiac surgery elderly postoperative complications patients aged 75 years or older undergoing cardiac surgery
effectiveness of a psycho-educational group (peg) intervention on supportive care and survivorship issues in early-stage breast cancer survivors who have received systemic treatment

Conditions: Breast Cancer; Cancer; Anxiety; Cognitive Dysfunction

Summary: as cancer mortality rates improve in asia, there is an increasing focus on patient-reported outcomes and survivorship issues. in view of the numerous medication and psychosocial issues that are commonly faced by early-stage breast cancer survivors, it deems important to develop and conduct specific interventional programs to mitigate these problems. in the literature, it is well recognized that psychosocial interventions are effective to manage emotional distress and quality of life, with the evidence clearly clustered in studies on female patients with breast cancer. one meta-analysis suggested that psycho-oncologic interventions including individual psychotherapy, group psychotherapy, psychoeducation, relaxing training can produce positive effects on emotional distress, anxiety and depression, and health-related qol. the investigators hypothesize that a significant reduction in anxiety, improvement of cognition and improvement of health-related quality of life among those who receive psycho-education, in comparison to those in the usual care. hence, this randomized trial is designed to assess the effectiveness of a psycho-educational group (peg) intervention on supportive care and survivorship issues, which include anxiety, depression, cognitive function, toxicities management of cancer- or treatment- related physical symptoms, and health-related quality of life in early-stage breast cancer patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed with breast cancer were included if they met the following criteria: * 21 years or older * able to read and understand either english or mandarin * diagnosis of stages 1-3 breast cancer by a medical oncologist * completed adjuvant cytotoxic treatment exclusion criteria: * diagnosed with severe psychiatric diagnosis such as severe cognitive disorders, mood disorders (psychiatric disorders requiring hospitalization) or serious personality disorders).
impact of bacillus clausii administration on irritable bowel syndrome patients

Conditions: Irritable Bowel Syndrome

Summary: probiotics have been proposed as useful therapeutic alternatives for the treatment of irritable bowel syndrome patients. bacillus clausii is a probiotic that has been used for the treatment of acute diarrhea among adults and pediatric patients, as well as an adjunctive therapy for the treatment for helicobacter pylori infection. it has been proposed that bacillus clausii is effective for the treatment of irritable bowel syndrome-related symptoms (especially diarrhea and bloating) in non-controlled trials. the aim of the proposed investigation is to determine whether the administration of bacillus clausii during two weeks plus dietary advice compared to antispasmodics plus dietary advice would be an effective and safe alternative.


Eligibility criteria:
inclusion criteria: * adult patients with non-constipated irritable bowel syndrome according to rome iv criteria exclusion criteria: * allergy to bacillus clausii spores * prior treatment with antibiotics or probiotics (4 weeks) * not willing to fulfill symptom diary * pregnancy or breastfeeding * clinical suspicion of organic disease
a pilot study assessing duloxetine's efficacy in atypical depression

Conditions: Atypical Depression

Summary: this is a pilot study to get a first indication whether duloxetine may be effective for depressed patients with atypical features.

this open pilot study will assess whether duloxetine is effective for patients with atypical features. 20 patients having major depressive disorder with atypical features or dysthymic disorder will receive duloxetine in open fashion for 8 weeks. dose will begin with 20 mg/d and increase to pdr maximal dose of 120 mg/d, if tolerated.

Eligibility criteria:
inclusion criteria: * dsm-iv major depression or dysthymia with atypical features * age 18-65 * physically healthy * hamd(24) \> 14 exclusion criteria: * prior experience with duloxetine * history of psychosis or bipolar disorder, borderline personality disorder * unstable medical disorder; any history of epilepsy * currently taking medication that can interact with duloxetine * current (past six months) substance use disorder (illicit drugs and/or alcohol) * serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization * current (past two weeks) use of psychoactive medication (four weeks for fluoxetine) * pregnancy * currently breast feeding * fecund women failing to use acceptable birth control * refractory depression (defined as failure to respond to one or more adequate trials of marketed antidepressants \[i.e., \>=2/3 pdr maximum dose for at least 4 weeks\] during current episode) * serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to icu, any duration of coma) * currently taking medication deemed effective

Keywords: atypical depression major depressive disorder dysthymic disorder atypical features duloxetine
use of cryoenergy to faciltate myectomy in hypertrophic obstructive cardiomyopathy: comparison with the classical approach

Conditions: Septal Hypertrophy; Obstructive Hypertrophic Cardiomyopathy

Summary: in some patients, septal hypertrophy extends more distally, from the subaortic portion of the septum to the midventricular portion. in these patients, classic transaortic surgical myectomy may not be effective in removing the midventricular obstruction, resulting in a suboptimal surgical outcome. these patients may present recurrence of symptoms and not have an improvement in the prognosis related to the treatment of hypertrophic cardiomyopathy, in some cases determining the need for reoperation. since 2015, our institute has used a surgical technique that allows us to improve transaortic exposure of the interventricular septum, using a probe with application of cryoenergy the hypertrophic portion of the septum is hooked and in this way the myectomy can be extended more distally, performing a more complete removal of the myocardium. the aim of this study is to compare the results obtained with classical myectomy compared to myectomy performed with the aid of cryoenergy. the primary endpoint is the comparison in terms of mortality between patients undergoing classical myectomy versus those undergoing cryoenergy-assisted myectomy. secondary endpoints are: extent of myectomy, persistence of residual left ventricular outflow tract obstruction, persistence of mitral regurgitation related to systolic anterior motion of the mitral leaflets, occurrence of ventricular defect, and need for pm implantation.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years) * meeting the clinical and echocardiographic criteria that made them candidates for isolated myectomy or in combination with other surgical procedures: * lv outflow tract instantaneous peak gradient \>50mmhg at rest or during stimulation * interventricular septum \>16mm, * nyha functional class iii-iv, despite maximal medical therapy * operated in san raffaele hospital with classic or cryo myectomy between 2015 and 2018. exclusion criteria: * extent of myectomy not reported in the operative report; * left ventricular outflow tract gradient not reported in pre- or postoperative echocardiography.
mazankowski alberta heart institute (mahi) echogo discovery 1 protocol

Conditions: Cardiotoxicity; Cancer

Summary: this study aims to compare conventionally acquired left ventricle ejection fraction (lvef) and global longitudinal strain (gls) data to artificial intelligence (ai) driven automated processing of 2 dimensional contrast and 2 dimensional non-contrast resting transthoracic echocardiograms for application in the assessment of patients undergoing chemotherapy with cardiotoxic drugs. this is a single-centre retrospective study which utilizes echocardiographic dicom image and meta-data datasets received from a canadian site. data processed using the ai driven automated processing will be compared to conventionally acquired lvef and gls measurements and results will be analysed to determine accuracy and precision.


Eligibility criteria:
inclusion criteria: * normal ef and no regional wall motion abnormalities prior to starting chemotherapy treatment. * follow-up ef measurements available for at least 1 year during the treatment period. * follow-up ef measurements for at least 1 year during the treatment period. exclusion criteria: * age \< 18 years * inadequate image quality (as determined by the ultromics operators quality control process)
diabetes nutrition algorithms - sugars: galactose- and fiber-induced metabolic improvement in the dietetic treatment of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: in animal models and retrospective studies, certain food components such as sugars and fiber have been detected as potential agents to influence development and progress of type 2 diabetes. the dina study prospectively investigates, if non-soluble non-fermentable fibers (vs. soluble ones) and galactose (vs. palatinose) are capable to improvement metabolic parameters in patients with long-term type 2 diabetes and intensive insulin treatment.


Eligibility criteria:
inclusion criteria: * type 2 diabetes, insulin-dependent * high insulin resistance exclusion criteria: * accompanying disease, medication or metabolic disorder, which interact with glucose metabolism or eating behavior (e.g. renal insufficiency, major cardial insuffiency, untreated hypothyreosis, corticoid treatment, depression and other psychiatric disorders...)

Keywords: type 2 diabetes nutrition fibers
pharmacokinetic, safety/tolerability study of a single sc dose of pb1023 injection in subjects with normal and impaired renal function

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: to compare the pharmacokinetic profile of glymera (pb1023) injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function. secondary objectives: to evaluate the safety and tolerability of glymera (pb1023) injection administered as a subcutaneous injection in adult subjects with normal renal function and impaired renal function.


Eligibility criteria:
inclusion criteria: * males and females age 18 - 79 years of age inclusive. * bmi 19 - 40 kg/m2. * renally impaired subjects: in otherwise stable health except for renal disease. * healthy volunteers must have/be: egfr as calculated by mdrd of ≥ 80 ml/min, and matched to renally impaired subjects for age (± 15 years), weight (± 15 kg), and if possible bmi, race and gender. * subjects with renal impairment must have 2 separate egfr that are within 20% of each other and clinically stable for a minimum of 6 months. * no clinically relevant abnormalities in the results of the laboratory screening or admission evaluation other than those consistent with renal impairment or related disease/disorder in the appropriate subject group as determined by the investigator. exclusion criteria: * currently taking or have taken a glp -1 agent (e.g., byetta®, victoza®) within the past year. * subjects who have previously received pb1023. * known allergy or serious adverse effect to an approved or investigational glp-1 receptor analog/agonist. * serious infection within 60 days of admission. * donation or loss of greater than 400 ml of blood 56 days prior to enrollment. * unstable cardiovascular disease defined as per protocol. * clinically significant hepatic dysfunction defined as per protocol. * female subjects who are pregnant, trying to become pregnant or lactating. * known history of or active alcohol or drug abuse within 12 months prior to screening or positive alcohol and/or drug screen. * positive for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibodies. * participating in any other study at time of screening other than observational studies or have received any other investigational drug or device within 30 days or 5 half-lives prior to dosing or are taking part in a non-drug study which in the opinion of the investigator would interfere with the outcome of the study.